Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Recruiting Study icon

Recruiting

Trial ID CA061-1001  |   NCT05869955

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • 40
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

print Print
email Email

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:.
    1. Fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria of SLE.
      1. Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening.
      2. SLE disease activity:.
        1. Active disease at screening, with recent ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system).
          1. Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.
          2. Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.
            1. Fulfilling the 2017 EULAR/ACR classification criteria for probable or definite IIM.
              1. Participant diagnosed with the following IIM subgroups: dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and polymyositis (PM).
                1. Presence of at least 1 myositis specific antibody (MSA), associated antibody (MAA), or ANA at screening or prior to screening.
                2. IIM disease activity:.
                  1. Severe/moderate muscle AND/OR skin involvement.
                    1. Proof of activity as documented by:.
                      1. An active myositis-associated rash OR.
                      2. A recent muscle biopsy OR.
                      3. An elevated CK > 3 times the upper limit of normal OR.
                      4. Participants diagnosed IIM AND progressive Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT)
                    2. Inadequate response to glucocorticoids and at least 2 of the following treatments used for at least 3 months: azathioprine, methotrexate, cyclosporin A, tacrolimus, MMF, cyclophosphamide, IVIG, JAK inhibitors, and rituximab.
                    3. Diagnosis of Systemic Sclerosis (SSc) defined as follows:.
                      1. Fulfilling 2013 EULAR/ACR classification criteria for SSc.
                        1. Antinuclear Antibody (ANA) positive at screening or prior to screening.
                        2. SSc disease activity:.
                          1. Participants diagnosed with diffuse cutaneous SSc OR diffuse or limited cutaneous SSc AND progressive ILD, AND.
                            1. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or intravenous immunoglobulins (IVIG).
                            2. Rheumatoid Arthritis (RA) disease activity:.
                              1. Minimum of 3 SJC and 3 TJC on a 66/68 joint count (SJC/TJC).
                                1. Inadequate response to ≥ 3 immunosuppressive therapies (IST)

                                Exclusion Criteria

                                Exclusion Criteria Icon
                                • Diagnosis of drug-induced SLE rather than idiopathic SLE.
                                  1. Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
                                    1. SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.
                                      1. Present or recent clinically significant CNS pathology, within 12 months.
                                        1. IIM disease activity:.
                                          1. Other forms of IIM: Inclusion Body Myositis, Amyopathic DM, any form of juvenile myositis.
                                            1. Myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.
                                              1. Participants with severe muscle damage (Physician VAS for muscle damage in Myositis Damage Index > 7 cm on a 10 cm scale), permanent weakness due to a non-IIM cause (eg, stroke), or myositis with cardiac involvement.
                                              2. SSc disease activity:.
                                                1. SSc related PAH requiring active treatment.
                                                  1. Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.
                                                    1. Prior scleroderma renal crisis.
                                                    2. RA disease activity:.
                                                      1. Prior history of or current inflammatory joint disease other than RA.
                                                        1. Joint damage and/or deformity that may confound the investigator's ability to accurately assess disease activity.
                                                        2. Other protocol-defined Inclusion/Exclusion criteria apply.
                                                          Additional Information *

                                                          Treatment Options

                                                          Study Arms

                                                          ASSIGNED INTERVENTION

                                                          Study Arms

                                                          Experimental: Administration of CC-97540

                                                          ASSIGNED INTERVENTION
                                                          • Drug: CC-97540, Fludarabine, Cyclophosphamide, Tocilizumab
                                                          Take the first step to see if you Match to a Clinical Trial – Check if you qualify
                                                          Check if you qualify
                                                          Answer some questions about Your health to see if you may match to this trial
                                                          Match to a Trial
                                                          If you are a match, click on the study to see the list of study site locations
                                                          Select a Study Site Location
                                                          Select a study site location that is convenient for you
                                                          Register
                                                          Provide your contact details for the study site to connect with you.

                                                          Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you